MedTrace Logo

A Study to Assess the Efficacy, Safety and Tolerability of VLS-01 Buccal Film, Compared to Placebo in Patients With Treatment Resistant Depression (ELUMINA)

NCT06524830 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2026-05-11

No results posted yet for this study

Summary

This Phase 2 study (protocol number VLS-01-203) will determine the efficacy, safety, and tolerability of short-term treatment with a VLS-01 transmucosal buccal film (VLS-01-BU) in patients with treatment resistant Major Depressive disorder (TRD) and will characterize the onset and durability of antidepressant effects of VLS-01-BU versus placebo.

Conditions

Interventions

DRUG

VLS-01-203 BU

VLS-01 buccal transmucosal administration

DRUG

VLS-01-BU Placebo

Placebo buccal transmucosal administration

Sponsors & Collaborators

  • atai Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-30
Primary Completion
2026-08-01
Completion
2026-08-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06524830 on ClinicalTrials.gov